Multi-vitamin and mineral supplement

ABSTRACT

This invention is directed to a multi-vitamin and mineral supplement tailored to men and post-menopausal women, pre-menopausal women, and athletes which supplies the right amount of the right micronutrients at the right time to assure adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies due to lifestyle factors and common inadequate dietary patterns. The multi-vitamin and mineral supplement is comprised of vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, niacinamide, vitamin B6, vitamin B12, biotin, pantothenic acid, iron, iodine, magnesium, zinc, selenium, copper, chromium, potassium, choline, lycopene, and co-enzyme Q-10.

BACKGROUND OF THE INVENTION

This invention relates to multi-vitamin and mineral supplements. Inparticular, this invention relates to multi-vitamin and mineralsupplements for improving health by insuring adequate intake ofmicronutrients needed for disease prevention and protection againstnutritional losses and deficiencies due to such factors as lifestylepatterns and common inadequate dietary patterns. More particularly, thisinvention related to multi-vitamin and mineral supplements for men andpost-menopausal women.

Vitamin and mineral preparations are commonly administered to treatspecific medical conditions or as general nutritional supplements.Micronutrients are elements or compounds which are present in foods insmall or trace amounts and includes vitamins, minerals, or otherelements, and compounds found in foods for which a Recommended DailyAllowance (RDA) has not yet been determined. The macronutrients consistof carbohydrates, fats, and proteins which supply nutrients andcalories. Some elements such as calcium, sodium, potassium, chloride,and phosphorus are consumed in relatively large amounts, while many suchas iron, iodine, and zinc are consumed in small amounts. Vitamins suchas B12 and folic acid and the minerals cooper, selenium, and chromiumare consumed in very small or trace amounts. In as much as the humanbody does not synthesize many compounds which are essential to the humanbody, these specific vitamins and minerals can be obtained from only twosources: food and supplements. The primary source of all nutrients isfood. However, the majority of people do not meet the RDA of the foodscontaining these essential compounds and elements. Thus vitamin andmineral supplementation has become a recognized method of meetingaccepted medical and health standards.

An international panel of diet and cancer experts announced in London onSep. 30, 1997, that as many as 30 to 40 percent of all cancer casesworldwide—3 to 4 million a year—could be avoided if people ate a healthydiet and got enough exercise. USA Today, Oct. 1, 1997. However, for somenutrients, the amounts proposed as being healthy apparently cannot beprovided by a reasonable quantity and variety of natural foods. Thusnutrient supplements may be important for health promotion andprevention of chronic diseases. Journal of the American MedicalAssociation, May 7, 1997.

Recent studies have illustrated the important physiological roles playedby vitamins and minerals and established a correlation betweendeficiencies or excesses of these nutrients and the etiologies ofcertain disease states in humans. Homocysteine is a homolog of cysteineand is produced by the demethylation of methionine, and is anintermediate in the biosynthesis of cysteine from methionine viacystathionine. Homocysteine is being referred to as the “cholesterol ofthe 21^(st) century.” Homocysteine is not inherently bad, as it is anecessary by-product in the break down of the essential amino acidmethionine, which is found primarily in red meat and diary products.However, as with cholesterol, homocysteine may get out of balance as aresult of genetics or poor diet. The main concern is having too muchhomocysteine.

As stated in the Journal of the American Medical Association, “A highlevel of homocysteine confers a risk of vascular disease similar to thatof cigarette smoking, elevated cholesterol, and other blood lipids.Also, it increases the risk associated with smoking and high bloodpressure.” Journal of the American Medical Association, Jun. 11, 1997.Elevated blood levels of homocysteine increase the risk ofatherosclerosis, a clogging of the arteries that is the main factor inthe majority of heart attacks and strokes. Elevated homocysteine levelsare found in 25% of heart attack patients, 40% of stroke patients, andmay also be associated with Alzheimer's disease.

It has recently been discovered that folic acid, when combined withvitamins B6 and B12, has the potential of dramatically lower thehomocysteine levels, thereby protecting against highhomocysteine-related diseases. Journal of the American MedicalAssociation, Oct. 4, 1995.

Coronary artery disease is one of the major causes of heart attacks andoccurs when there is atherosclerosis in the vital coronary arteries,which supply the nutrient rich blood to the interior of the heartmuscle. High levels of LDL cholesterol have been linked to thedevelopment of atherosclerosis in the coronary arteries. However, freeradicals have received more attention as the culprit of the disease. Itappears that clogging occurs after the LDL cholesterol is oxidizedwithin the wall of the blood vessel by exposure to free radicals. Thewhite blood cells attempt to remove the damaged LDL cholesterol byengulfing them. Unfortunately, after ingesting the LDL cholesterol, thecells cannot rid themselves of the cholesterol portion and swell up,thus the process of atherosclerosis (thickening of the artery wall andnarrowing of the coronary arteries) begins. Therefore, it is not the LDLcholesterol that blocks the artery, but the oxidized LDL that has beenengulfed by the white blood cells that actually causes the damage.

Free radicals may be activated by factors such as cigarette smoke,pollution, excessive exercise, and other stressors. The LDL cholesterolcan fight these free radicals with antioxidants such as vitamins C andE, but before long the LDL's antioxidants are depleted and the LDL isleft defenseless. It has been discovered that at least 1000 mg ofvitamin C coupled with 1000 I.U. of vitamin E (d-alpha tocopherol) takenin conjunction with a 900-calorie meal containing 50 grams of fatblocked the detrimental effects of a fatty meal on blood circulation.Journal of the American Medical Association, Nov. 26, 1997. In addition,it has been discovered that 100 I.U. of vitamin E supplements taken fortwo years or longer reduced deaths of coronary artery disease by 40% in87,245 nurses and by 37% in 39,910 male health professionals. NewEngland Journal of Medicine, May 20, 1993.

There exists a need for a nutritional supplement for men andpost-menopausal women which supplies the right amount of the rightmicronutrients at the right time to assure adequate intake ofmicronutrients needed for disease prevention and protection againstnutritional losses and deficiencies due to lifestyle factors and commoninadequate dietary patterns.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided amulti-vitamin and mineral supplement specifically tailored to men andpost-menopausal women, pre-menopausal women, and athletes which suppliesthe right amount of the right micronutrients at the right time to assureadequate intake of micronutrients needed for disease prevention andprotection against nutritional losses and deficiencies due to lifestylefactors and common inadequate dietary patterns.

Further, in accordance with the present invention, there is provided anew and improved multi-vitamin and mineral supplement which can be usedfor providing the necessary nutrients to allow the users of suchsupplement to maintain their present health and positively influencetheir future health.

Still further in accordance with the present invention, there isprovided a multi-vitamin and mineral supplement wherein the supplementis comprised of from about 5000 I.U. to about 10,000 I.U. of vitamin A;from about 1000 mg to about 2000 mg of vitamin C; about 400 I.U. ofvitamin D; from about 800 I.U. to about 1200 I.U. of vitamin E; about 25mcg of vitamin K; about 3 mg of vitamin BI; about 10 mg of vitamin B2;about 20 mg of niacinamide; about 25 mg of vitamin B6; about 800 mcg offolic acid; about 400 mcg of vitamin B12; about 300 mcg of biotin; about10 mg of pantothenic acid; up to about 18 mg of iron dosed in the formof a pharmaceutically acceptable iron compound; about 150 mcg of iodinedosed in the form of a pharmaceutically acceptable iodine compound;about 400 mg of magnesium dosed in the form of a pharmaceuticallyacceptable magnesium compound; about 15 mg of zinc dosed in the form ofa pharmaceutically acceptable zinc compound; from about 100 mcg to about200 mcg of selenium; about 2 mg of copper dosed in the form of apharmaceutically acceptable copper compound; about 100 mcg of chromiumdosed in the form of a pharmaceutically acceptable chromium compound;about 400 mg of potassium dosed in the form of a pharmaceuticallyacceptable potassium compound; about 500 mg of choline dosed in the formof a pharmaceutically acceptable choline compound; about 10 mg oflycopene; and about 50 mg co-enzyme Q-10 dosed in the form of apharmaceutically acceptable co-enzyme Q-10 compound.

An advantage of the present invention is that the multi-vitamin andmineral supplement supplies the right amount of the right micronutrientsat the right time to assure adequate intake of micronutrients needed fordisease prevention and protection against nutritional losses anddeficiencies due to lifestyle factors and common inadequate dietarypatterns.

Another advantage of the present invention is that the multi-vitamin andmineral supplement provides the necessary nutrients to allow the usersof such supplement to maintain their present health and positivelyinfluence their future health.

Another advantage of the present invention is that the multi-vitamin andmineral supplement decreases plasma homocysteine levels, reduces thesusceptibility of LDL cholesterol to oxidation, and lowers plasmaglucose levels.

These and other advantages and benefits of the invention will beapparent to those skilled in the art upon reading and understanding ofthe following detailed description.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

This invention is directed to a multi-vitamin and mineral supplementcomprised of from about 5000 I.U. to about 10,000 I.U. of vitamin A;from about 1000 mg to about 2000 mg of vitamin C; about 400 I.U. ofvitamin D; from about 800 I.U. to about 1200 l.U. of vitamin E; about 25mcg of vitamin K; about 3 mg of vitamin B1; about 10 mg of vitamin B2;about 20 mg of niacinamide; about 25 mg of vitamin B6; about 800 mcg offolic acid; about 400 mcg of vitamin B12; about 300 mcg of biotin; about10 mg of pantothenic acid; up to about 18 mg of iron dosed in the formof a pharmaceutically acceptable iron compound; about 150 mcg of iodinedosed in the form of a pharmaceutically acceptable iodine compound;about 400 mg of magnesium dosed in the form of a pharmaceuticallyacceptable magnesium compound; about 15 mg of zinc dosed in the form ofa pharmaceutically acceptable zinc compound; from about 100 mcg to about200 mcg of selenium; about 2 mg of copper dosed in the form of apharmaceutically acceptable copper compound; about 100 mcg of chromiumdosed in the form of a pharmaceutically acceptable chromium compound;about 400 mg of potassium dosed in the form of a pharmaceuticallyacceptable potassium compound; about 500 mg of choline dosed in the formof a pharmaceutically acceptable choline compound; about 10 mg oflycopene; and about 50 mg co-enzyme Q-10 dosed in the form of apharmaceutically acceptable co-enzyme Q-10 compound.

All amounts specified in the application are based on milligrams unlessotherwise indicated. The term “I.U.” represents International Units.

The multi-vitamin and mineral supplement is comprised of vitamin A.Vitamin A prevents night blindness and other eye disorders, keeps skinmoist and elastic, maintains healthy hair, skin, and gums, reduces therisk of breast cancer, helps alleviate mastodynia, reduces the risk oflung cancer, maintains cell structure and integrity, works asantioxidant to prevent cell aging, helps prevent infection, and negatesskin wrinkling and the effects of sun damage. Vitamin A is a fat solublevitamin. The term vitamin A is used to include retinol and otherchemically similar compounds referred to as retanoids. Beta-carotene andother carotenoids are provitamins and are only turned into retinol asthe body requires. Preferably, in the multi-vitamin and mineralsupplement, vitamin A is provided in the form of beta-carotene and othermixed carotenoids. Preferably, the mixed carotenoids are lutein andzeaxanthine. Lutein and zeaxanthine have been found to decrease the riskand even reverse the development of macular degeneration, the leadingcause of blindness in those over the age of 65.

For premenopausal women, post-menopausal women, and men, themulti-vitamin is preferably comprised of about 5000 I.U of vitamin A andabout 6000 mcg of lutein and zeaxanthine. More preferably, themulti-vitamin and mineral supplement is comprised of about 5000 I.U. ofvitamin A in the form of natural mixed beta-carotene and about 6000 mcgof lutein and zeaxanthine. The amount of lutein and zeaxanthine presentin the multi-vitamin and mineral supplement must be sufficient to ensurethat one's intake of these carotenoids is adequate to achieve thebenefits associated with these carotenoids.

For athletes, the multi-vitamin is preferably comprised of about 10,000I.U of vitamin A and about 6000 mcg of lutein and zeaxantine. Morepreferably, the multi-vitamin and mineral supplement is comprised ofabout 10,000 I.U. of vitamin A in the form of natural mixedbeta-carotene and about 6000 mcg of lutein and zeaxanthine. The higherlevel of vitamin A present in this formulation is required to fight thehigh level of free-radicals produced by athletes. The body's need foroxygen during exercise produces free radicals, which can oxidize thefats in muscle cell membranes in a process known as “lipid preoxidation”and which make the cells more susceptible to aging and other damage.

Vitamin C, also known as ascorbic acid, is necessary for the synthesisof collagen and is used as an antioxidant. Vitamin C fights infection,reduces inflammation, heals wounds, reduces the risk of heart disease,lowers cholesterol, reduces the risk of lung, stomach, and esophagealcancers, reduces cervical epithelial abnormalities, inhibitsN-nitrosamine, and reduces the severity of colds.

For pre-menopausal women, post menopausal women, and men, themulti-vitamin and mineral supplement is preferably comprised of about1000 mg of vitamin C. For athletes, the multi-vitamin and mineralsupplement is preferably comprised of about 2000 mg of vitamin C. Thehigher level of vitamin C is required to fight the high level offree-radicals produced by athletes and helps to revive vitamin E.

Vitamin D is also an essential vitamin that is included in themulti-vitamin and mineral supplement of the present invention. Vitamin Dassists in the mineralization and calcification of bone, preventsrickets in children, prevents osteomalacia in adults, preserves bone andtooth growth, and lowers blood pressure. Vitamin D is fat soluble.Preferably, the multi-vitamin and mineral supplement is comprised ofabout 400 l.U. of vitamin D.

Vitamin E is needed for the maintenance of cell membranes and forneurological health.

Vitamin E relieves hot flashes, relieves mastodynia, helps in fightingfibrocystic breast disease, reduces mammary tumors, reduces the risk oflung cancer, and reduces the risk of heart disease.

Vitamin E is the generic term for a group of related substances whichinclude alpha-tocopherol, beta-tocopherol, gamma-tocopherol, anddelta-tocopherol. In addition, each of these four compounds have a “d”form, which is the natural form, and a “dl” form which is the syntheticform. Preferably, in the multi-vitamin and mineral supplement, vitamin Eis provided in the form of d-alpha tocopherol succinate.

For pre-menopausal women, post-menopausal women, and men, themulti-vitamin and mineral supplement is preferably comprised of about800 I.U. of vitamin E. More preferably, the multi-vitamin and mineralsupplement is comprised of about 800 I.U. of vitamin E in the form ofd-alpha tocopherol succinate. Research has shown that 400 I.U. ofvitamin E is the minimum dosage needed to significantly decreasesusceptibility of LDL cholesterol to oxidation. Patients with coronaryatherosclerosis which were taking 400 or 800 I.U. of vitamin E daily hada statistically significant reduction in the incidence of non-fatalmyocardial infarction. Therefore, the amount of vitamin E present in themulti-vitamin and mineral supplement must be sufficient to ensure thatthat one's intake of vitamin E is adequate to achieve the benefitsassociated with vitamin E.

For athletes, the multi-vitamin and mineral supplement is preferablycomprised of about 1200 I.U. of vitamin E. More preferably, themulti-vitamin and mineral supplement is comprised of about 1200 I.U. ofvitamin E in the form of d-alpha tocopherol succinate. The higher levelof vitamin E present in this formulation is required to fight the highlevel of free-radicals produced by athletes.

The multi-vitamin and mineral supplement includes vitamin K. Vitamin Kis an active blood clotting agent and assists in bone formation.Preferably, the multi-vitamin and mineral supplement is comprised ofabout 25 mcg of vitamin K.

The multi-vitamin and mineral supplement is comprised of most of the Bcomplex of vitamins. The B vitamins are water-soluble. The B vitaminsincluded in the multi-vitamin and mineral supplement are thiamin(vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenicacid (vitamin B5), pyridoxine (vitamin B6), biotin, folic acid, thecobalamins (vitamin B12), and choline.

Vitamin B1 or thiamin helps keep collagen-rich connective and mucousmembranes healthy, helps to maintain smooth muscles, helps in theformation of blood cells, and is necessary for proper nervous systemfunction. Preferably, the multi-vitamin and mineral supplement iscomprised of about 3 mg of vitamin B1.

Vitamin B2 or riboflavin is necessary for healthy hair, nails, andmucous membranes and is involved in red blood cell formation, antibodyproduction, and overall growth. Preferably, the multi-vitamin andmineral supplement of the present invention is comprised of about 10 mgof vitamin B2.

Vitamin B3 or niacin helps in the production of most of the sexhormones, dilates blood vessels, lowers cholesterol, and helps maintainblood circulation. Niacin is the generic name for a group of compoundswhich exhibit niacin activity, and includes niacinamide and nicotinicacid. Preferably, in the multi-vitamin and mineral supplement, vitaminB3 is provided as niacinamide. Preferably, the multi-vitamin and mineralsupplement is comprised of about 20 mg of vitamin B3. More preferably,the multi-vitamin and mineral supplement is comprised of about 20 mg ofvitamin B3 in the form of niacinamide.

Vitamin B6 or pyridoxine is involved in the production of ribonucleicacid (RNA) and deoxyribonucleic acid (DNA) and many other reactions inthe body. Pyridoxine refers to and includes three different compounds:pyridoxine, pyridoxamine, and pyridoxal. Preferably, in themulti-vitamin and mineral supplement, vitamin B6 is in the form ofpyridoxine hydrochloride.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 25 mg of vitamin B6. More preferably, the multi-vitamin andmineral supplement is comprised of about 25 mg of vitamin B6 in the formof pyridoxine hydrochloride. Vitamin B6, when combined with folic acidand vitamin B12, has been found to decrease homocysteine levels. Suchdecreases in homocysteine levels have been found with about 25 mg toabout 50 mg of vitamin B6.

Folic acid is essential in the production of red blood cells, theproduction of hormones, and the synthesis of DNA. Preferably, themulti-vitamin and mineral supplement is comprised of about 800 mcg offolic acid.

Vitamin B12 or the cobalamins is necessary for overall metabolism, thefunction of the nervous system, metabolism of folic acid, and theproduction of red blood cells. There are at least three active forms ofcobalamin: cyanocobalamin, hydroxocobalamin, and nitrocobalamin.Preferably, in the multi-vitamin and mineral supplement of the presentinvention, vitamin B12 is provided in the form of cyanocobalamin.Preferably, the multi-vitamin and mineral supplement is comprised ofabout 400 mcg of vitamin B12. More preferably, the multi-vitamin andmineral supplement is comprised of about 400 mcg of vitamin B12 in theform of cyanocobalamin.

Biotin is necessary for the metabolism of carbohydrates, proteins, andfats and is needed for healthy skin and hair. Preferably, in themulti-vitamin and mineral supplement, biotin is provided in the form ofd-biotin. Preferably, the multi-vitamin and mineral supplement iscomprised of about 300 mcg of biotin. More preferably, the multi-vitaminand mineral supplement is comprised of about 300 mcg of biotin in theform of d-biotin.

Pantothenic acid is important for the production of adrenal glandhormones, increases overall energy, and helps convert food into energy.Preferably, in the multi-vitamin and mineral supplement, pantothenicacid is in the form of d-calcium pantothenate. Preferably, themulti-vitamin and mineral supplement is comprised of about 10 mg ofpantothenic acid. More preferably, the multi-vitamin and mineralsupplement is comprised of about 10 mg of pantothenic acid in the formof d-calcium pantothenate.

Choline is necessary for nervous system function and brain function. Itis also important for gall bladder and liver function. Preferably, inthe multi-vitamin and mineral supplement, choline is provided in theform choline bitartrate. Preferably, the multi-vitamin and mineralsupplement is comprised of about 500 mg of choline. More preferably, themulti-vitamin and mineral supplement is comprised of about 500 mg ofcholine in the form of choline bitartrate.

Iron is used in the production of hemoglobin and myoglobin. In themulti-vitamin and mineral compound, the iron is dosed in the form of apharmaceutically acceptable iron compound. As used herein,pharmaceutically acceptable is a component which is suitable for use inhumans without undue side effects, such as irritation, toxicity, andallergic response. Useful pharmaceutically acceptable iron compoundsinclude, but are not limited to, ferrous fumarate, ferrous sulfate, ironcarbonyl, ferrous glucomate, ferrous chloride, ferrous lactate, ferroustartrate, ferrous succinate, ferrous glutamate, ferrous citrate, ferrouspyrophosphate, ferrous cholinisocitrate, ferrous carbonate,iron-sugar-carboxylate complexes, and combinations thereof. Preferably,the pharmaceutically acceptable iron compound is iron carbonyl. Ironcarbonyl is easier on the digestive tract than other forms of iron, suchas ferrous fumerate. In addition, the Food and Drug Administration doesnot require a warning label on the toxicity to children for this form ofiron as it is safe for children who accidentally ingest this form ofiron.

For post-menopausal women and men, the multi-vitamin and mineralsupplement is substantially free of iron. Research has shown that highstored levels of iron are associated with an increased risk ofmyocardial infarction. Post menopausal women and men do not needadditional iron through supplements, unless otherwise recommended by aphysician. In addition, a growing percentage of the population suffersfrom a disease known as hemochromatosis, an abnormally high level ofiron in the blood. These people cannot take iron in supplement form.

For pre-menopausal women and athletes, the multi-vitamin and mineralcompound is preferably, comprised of about 18 mg of iron dosed in apharmaceutically acceptable iron compound. More preferably, themulti-vitamin and mineral supplement is comprised of about 18 mg of irondosed in the form of iron carbonyl. Women in their child-bearing yearsneed supplemental iron as deficiencies are common. Iron deficiencies arealso common in athletes.

Iodine helps to metabolize fats, is necessary for proper thyroidfunction, and reduces fibrocystic breast conditions. In themulti-vitamin and mineral supplement of the present invention, iodine isdosed in the form of a pharmaceutically acceptable iodine compound.Useful pharmaceutically acceptable iodine compounds include, but are notlimited to, potassium iodide, sodium iodide, and combinations thereof.

Preferably, the pharmaceutically acceptable iodine compound is potassiumiodide. Preferably, the multi-vitamin and mineral supplement iscomprised of about 150 mcg of iodine dosed in the form of apharmaceutically acceptable iodine compound. More preferably, themulti-vitamin and mineral supplement is comprised of about 150 mg ofiodine dosed in the form of potassium iodide.

Magnesium is used in bone formation and growth, prevents bone loss,relaxes coronary arteries, is used in managing pre-eclampsia, treatingcardiac arrhythmias, and managing diabetes.

In the multi-vitamin and mineral supplement, magnesium is dosed in theform of a pharmaceutically acceptable magnesium compound. Usefulpharmaceutically acceptable magnesium compounds include, but are notlimited to, magnesium stearate, magnesium carbonate, magnesium oxide,magnesium hydroxide, magnesium sulfate, and combinations thereof.

Preferably, the pharmaceutically acceptable magnesium compound ismagnesium oxide.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 400 mg of magnesium dosed in the form of a pharmaceuticallyacceptable magnesium compound. More preferably, the multi-vitamin andmineral supplement is comprised of about 400 mg of magnesium dosed inthe form of magnesium oxide.

Zinc is required for proper formation of DNA and RNA and is needed forgrowth and sexual development of women. In the multi-vitamin and mineralsupplement of the present invention, zinc is dosed in the form of apharmaceutically acceptable zinc compound.

Pharmaceutically acceptable zinc compounds include, but are not limitedto, zinc sulfate, zinc chloride, zinc oxide, and combinations thereof.Preferably, the pharmaceutically acceptable zinc compound is zinc oxide.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 15 mg of zinc dosed in the form of a pharmaceutically acceptablezinc compound. More preferably, the multi-vitamin and mineral supplementis comprised of about 15 mg of zinc dosed in the form of zinc oxide.

Selenium reduces the risk of heart attacks and heart disease, reducesthe risk of cancer, protects against metal poisoning, and is synergisticwith vitamin E. Preferably, in the multi-vitamin and mineral supplement,selenium is obtained from rice bran chelate.

For pre-menopausal women, post-menopausal women, and men, themulti-vitamin and mineral supplement is preferably comprised of about100 mcg of selenium. For athletes, the multi-vitamin and mineralsupplement is preferably comprised of about 200 mcg of selenium.

The higher level of selenium is required to fight the high level offree-radicals produced by athletes and selenium works synergisticallywith vitamin E.

Copper helps keep blood vessels elastic, is needed for the formation ofelastin and collagen, functions as an iron oxidizer, and is needed forthe proper functioning of vitamin C. In the multi-vitamin and mineralsupplement, copper is dosed in a pharmaceutically acceptable coppercompound. Pharmaceutically acceptable copper compounds include, but arenot limited to, cupric oxide, cupric sulfate, cupric gluconate, andcombinations thereof. Preferably, the pharmaceutically acceptable coppercompound is cupric gluconate.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 2 mg of copper dosed in the form of a pharmaceutically acceptablecopper compound. More preferably, the multi-vitamin and mineral compoundis comprised of about 2 mg of copper dosed in the form of cupricgluconate.

Chromium assists in the regulation of glucose metabolism, is used in thesynthesis of fatty acids and cholesterol, assists in transportingproteins, lowers LDL blood levels, and raises high density lipoproteinsblood levels. In the multi-vitamin and mineral supplement, chromium isdosed in a pharmaceutically acceptable chromium compound. Usefulpharmaceutically acceptable chromium compounds include, but are notlimited to, yeast-bound chromium, GTF chromium, niacin-bound chromium.Preferably, the pharmaceutically acceptable chromium compound ischromium amino acid chelate.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 100 mcg of chromium dosed in the form of a pharmaceuticallyacceptable chromium compound. More preferably, the multi-vitamin andmineral supplement is comprised of about 100 mcg of chromium dosed inthe form of chromium amino acid chelate. Chromium is present in themulti-vitamin and mineral supplement at a level that meets the 100%daily value. Research has shown that the average person consumes lessthan 50 mcg of chromium a day.

Potassium is needed to regulate water balance, levels of acidity, bloodpressure, and neuromuscular function. Potassium is also required forcarbohydrate and protein metabolism. In the multi-vitamin and mineralsupplement, potassium is dosed in the form of a pharmaceuticallyacceptable potassium compound. Useful pharmaceutically acceptablepotassium compounds include, but are not limited to, potassium chloride,potassium glycerophosphate, potassium citrate, potassium gluconate,potassium phosphate, and combinations thereof. Preferably, thepharmaceutically acceptable potassium compound is potassium phosphate.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 400 mg of potassium dosed in the form of a pharmaceuticallyacceptable potassium compound. More preferably, the multi-vitamin andmineral supplement is comprised of about 400 mg of potassium dosed inthe form of potassium phosphate.

Lycopene has been found to reduce the risk of cancer and has antioxidantcapabilities. Lycopene is found primarily in tomatoes, red grapefruit,watermelon, and other sources, and is a carotenoid. Preferably, in themulti-vitamin and mineral supplement, the lycopene is obtained fromtomatoes.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 10 mg of lycopene. Lycopene has been linked to lower rates ofprostate cancer. Research has shown that four to seven servings of redtomato products per week can reduce deaths from prostate cancer by 20%.Therefore, the amount of lycopene present in the multi-vitamin andmineral supplement must be sufficient to ensure that that one's intakeof lycopene is adequate to achieve the benefits associated withlycopene.

Co-enzyme Q10, also known as ubiquinone, is an antioxidant whichprotects the body from radicals. Co-enzyme Q10 aids metabolic reactions,such as the complex process of transforming food into ATP, and helpspeople with congestive heart failure and angina. Co-enzyme Q10 isdepleted in people taking lovastatin and pravastatin which arecholesterol lowering drugs.

Preferably, the multi-vitamin and mineral supplement is comprised ofabout 50 mg of co-enzyme Q10. Co-enzyme Q10 is very costly and theamount of co-enzyme Q10 present in the multi-vitamin and mineralsupplement is sufficient to ensure that that one's intake of co-enzymeQ10 is adequate to achieve the benefits associated with co-enzyme Q10.

The nutritional supplements of the present invention are suitablyprovided in any suitable dosage form known in the art. For example, thecompositions are suitably incorporated into tablets, powders, granules,beads, chewable lozenges, capsules, liquids, or similar conventionaldosage forms, using conventional equipment and techniques known in theart. Tablet dosage forms are preferred.

When preparing dosages forms incorporating the compositions of thepresent invention, the nutritional components are normally blended withconventional excipients such as binders, including gelatin,pregelatinzed starch, and the like; lubricants, such as hydrogenatedvegetable oil, stearic acid and the like; diluents, such as lactose,mannose, and sucrose; disintegants, such as carboxymethyl cellulose andsodium starch glycolate; suspending agents, such as povidone, polyvinylalcohol, and the like; absorbents, such as silicon dioxide;preservative, such as methylparaben, propylparaben, and sodium benzoate;surfactants, such as sodium lauryl sulfate, polysorbate 80, and thelike; and colorants, such as F.D & C. dyes and the like.

For preparing the composition from the compounds described by thisinvention, inert, pharmaceutically acceptable carriers are used whichare either solid or liquid form. Solid form preparations includepowders, tablets, dispersible granules, capsules, and cachets. A solidcarrier is suitably one or more substances which may also act asdiluents, flavoring agents, solubilizers, lubricants, suspending agents,binders or tablet disintegrating agents. The solid carrier material alsoincludes encapsulating material. In powders, the carrier is finelydivided active compounds. In the tablet, the active compound is mixedwith the carrier having the necessary binding properties in suitableproportions and compacted in the shape and size desired. Suitable solidcarriers include, but are not limited, to magnesium carbonate, magnesiumstearate, talc, sugar, lactose, pectin, dextrin, starch, gelatin,tragacanth, methylcellulose, sodium carboxymethylcellulose, a lowmelting wax, cocoa butter, and the like. The term preparation isintended to include the formulation of the active compounds withencapsulating material as the carrier providing a capsule in which theactive component (with or without other carriers) is surrounded bycarrier, which is thus in association with it. Tablets, powders,cachets, and capsules may be used in a solid dosage form suitable fororal administration.

Liquid form preparations include solutions, suspensions, and emulsions.Aqueous solutions suitable for oral use are prepared by dissolving theactive component in water or other suitable liquid and adding suitablecolorants, flavors, stabilizing agents, and thickening agents asdesired. Aqueous solutions suitable for oral use may also be made bydispersing the finely divided active component in water or othersuitable liquid with viscous material, such as natural or syntheticgums, resins, methylcellulose, sodium carboxymethylcellulose, and othersuspending agents known in the art.

Also included are solid form preparations which are intended to beconverted, shortly before use, to liquid form preparations for eitheroral or parental administration. Such liquid forms include solutions,suspensions, and emulsions. These particular solid form preparations areprovided in unit dose form and as such are used to provide a singleliquid dosage unit. Alternatively, sufficient solid preparation may beprovided so that the after conversion to liquid form, multipleindividual liquid doses may be obtained by measuring predeterminedvolumes of the liquid form preparation as with a syringe, teaspoon, orother volumetric contained.

The solid and liquid forms may contain, in addition to the activematerial, flavorants, colorants, stabilizers, buffers, artificial andnatural sweeteners, dispersants, thickeners, solubilizing agents, andthe like. The liquid utilized for preparing the liquid form preparationis suitably water, isotonic water, ethanol, glycerin, propylene glycol,and the like as well as combinations thereof. The liquid utilized willbe chosen with regard to the route of administration.

Preferably, the preparations are unit dosage form. In such form, thepreparation is subdivided into unit doses containing appropriatequantities of the active components. The unit dosage form can be apackaged preparation, such as packaged tablets or capsules. The unitdosage can be a capsule, cachet, or tablet itself or it can be theappropriate number of any of these in packaged form.

The quantity of active material in a unit dose of preparation is variedaccording to the particular application and potency of the activeingredients.

Determination of the proper dosage for a particular situation is withinthe skill of the art. For convenience, the total daily dosage may bedivided and administered in portions during the day if desired.Controlled and uncontrolled release formulations are also included.

Although the products of the invention are preferably intended foradministration to humans, it will be understood that the formulation mayalso be utilized in veterinary therapy for other animals.

The present invention is further exemplified in the following example Itis understood that the example is only for illustrative purposes whereinthe claims set forth the scope of the present invention.

EXAMPLE

The effect of the multi-vitamin and mineral supplement of the presentinvention on blood lipids, serum concentration of vitamins, serumconcentration of homocysteine, LDL oxidation rates, plasma glucoselevels, and levels of other elements in the blood was studied. Onehundred fifty-one human subjects participated in the study.

The participants underwent an initial six week washout period duringwhich no vitamin or mineral supplements, except calcium, were taken.After undergoing the six-week washout period, the participants had blooddrawn for blood chemistry analysis. After the washout period, theparticipants took the prescribed dosage of the multi-vitamin and mineralsupplement in the form of three tablets, twice daily with food for sixmonths. Participants returned to have their blood drawn and analyzed atthe end of three months of taking the supplement, and again at the endof the six month period. The participants were required to keep athree-day dietary record for the three days immediately prior to each ofthe blood draws. In addition, the participants were required to fast (tostop eating and drinking everything except water) for twelve hours priorto each blood draw.

All participants completed a vitamin supplement questionnaire as to whatsupplements were taken before the six week washout period. Thequestionnaires indicated that 34% were taking a multi-vitamin, 33% weretaking vitamin E, 38% were taking vitamin C, 22% were takingbeta-carotene, and 13% were taking selenium. At the end of the sixmonths, 2% of the participants were taking vitamin C, 1% were takingvitamin E, and 0.7% were taking a multi-vitamin and beta-carotenesupplement.

The demographic and medical information for the participants is shown inTable 1 below.

TABLE 1 Characteristics of Participants Female 48% Age (years) 50.9 ±12.3 Non-Hispanic White 93% Married 90% Education ≧ 16 years 77% Currentsmokers 5% Walk or Jog 61% Weight (kg) 76.2 ± 17.9 Height (m) 1.73 ±0.11 BMI(kg/m²) 25.3 ± 4.5 History of myocardial infarction 0.7% Historyof chest pain with exertion 2.8% History of stroke 0.7% History ofcancer 11% History of hypertension 14% History of high cholesterol 30%History of diabetes 0.7% History of thyroid disease 6% History ofarthritis 17% History of depression 11% Family history of CVD 29%

The blood chemistry analysis of the participants analyzed the level ofcertain blood lipids, such as cholesterol and triglycerides, and othercomponents present in blood serum. The results of this analysis is shownin Table 2 below.

TABLE 2 Blood lipids and other measurements in Participants VariableMonth 0 Month 3 Month 6 Cholesterol (mg/dl) 201.4 ± 41.6 199.0 ± 38.3207.6 ± 39.5 HDL-Chol (mg/dl)  58.6 ± 18.0  58.7 ± 17.5  59.4 ± 17.9LDL-Chol (mg/dl) 122.1 ± 65.0 114.8 ± 32.2 123.5 ± 33.3 VLDL-Chol(mg/dl)  24.6 ± 16.1  23.9 ± 13.8  24.6 ± 14.7 Triglyceride (mg/dl)123.3 ± 87.5 118.8 ± 73.2 121.9 ± 74.4 Glucose (mg/dl)  98.2 ± 15.8 94.1 ± 11.7***  94.7 ± 14.4*** Potassium (mEq/L)  4.5 ± 0.5  4.5 ± 0.5 4.6 ± 0.4 Sodium (mEq/L) 139.2 ± 2.0 140.2 ± 2.2 140.1 ± 2.2 Calcium(mg/dl)  8.9 ± 0.4  9.4 ± 6.1  8.9 ± 0.4 Phosphorus (mg/dl)  3.3 ± 0.4 3.3 ± 0.5  3.2 ± 0.4 Bilirubin (U/L)  0.7 ± 0.3  0.7 ± 0.3  0.7 ± 0.3ALT (U/L)  22.5 ± 11.2  27.5 ± 19.8***  27.4 ± 16.6*** AST (U/L)  20.2 ±5.1  23.6 ± 8.1***  24.0 ± 7.4*** ALP (U/L)  66.5 ± 15.9  64.9 ± 18.4 65.4 ± 14.9 All Protein (g/dl)  7.2 ± 0.4  7.3 ± 0.4  7.3 ± 0.4 Albumin(g/dl)  4.5 ± 0.3  4.4 ± 0.4  4.5 ± 0.4 Uric Acid (mg/dl)  5.4 ± 1.4 5.1 ± 1.3  5.1 ± 1.4 Urea Nitrogen  15.4 ± 3.8  15.2 ± 4.0  15.2 ± 3.6(mg/dl) Creatinine (mg/dl)  1.1 ± 0.2  1.1 ± 0.2  1.1 ± 0.2 LD (U/L)142.1 ± 24.0 145.1 ± 32.3 139.6 ± 27.1 CK (U/L) 104.6 ± 68.4 111.4 ±88.6 111.4 ± 88.6 ***P < 0.0001 when compared with month 0.

The expected range for total cholesterol is between 130-200 mg/dL. Table2 shows that the participants had a slightly higher than the expected ornormal values for total cholesterol. Cholesterol is further divided intohigh density cholesterol (HDL), low density cholesterol (LDL), and verylow density cholesterol (VLDL) fractions. HDL is known as the goodcholesterol because higher levels have been associated with a lower riskof cardiovascular disease and heart attacks. The normal levels for HDLare 45-70 mg/dL for men and 55-85 mg/dL for women. As shown in Table 4,the participants had a normal range of HDL for the duration of thestudy. LDL is known as the bad cholesterol as it has been linked to thedevelopment of atherosclerosis in the coronary arteries. The normalrange for LDL cholesterol is between 65-130 mg/dL. The participants hada normal range of LDL cholesterol, which remained consistent throughoutthe study, as shown in Table 2.

VLDL is another component of total cholesterol. More research must beconducted on VLDL to better understand its function. The normal range ofVLDL is 0-25 mg/dL for men and 0-14 mg/dL for women. The participantshad normal VLDL levels from the first visit to the third visit.

ALT, also known as alanine aminotransferase, and AST, also known asaspartate aminotransferase, are enzymes which are related to liverfunction in general. The normal range for ALT is 0-65 U/L and the normalrange for AST is 8-40 U/L. There was a significant increase in theseenzymes from the beginning of the study to the sixth month, althoughthese values did not approach or exceed the normal levels as indicated.

Glucose is blood sugar. Significantly high levels of glucose mayindicate a diabetic tendency or actual diabetes. Low levels of glucoseare suggestive of hypoglycemia. The expected or normal range for glucoseis 80-120 mg/dL. Another object of the study was to determine the effectof the supplement on fasting serum glucose. The results are shown inTable 2 and in Table 3 below.

TABLE 3 Effect of Supplement on Fasting Glucose Levels Variable N Month0 Month 3 Month 6  80-109 134  94.7 ± 6.8  91.7 ± 8.0***  91.7 ± 13.8***(mg/dl) 110-125  10 114.4 ± 3.6 110.2 ± 8.7 107.8 ± 8.7# (mg/dl) 126-205 4 173.0 ± 36.0 139.0 ± 30.5 136.5 ± 27.2 (mg/dl) All Subjects 148  98.2± 15.8  94.1 ± 12.7***  94.7 ± 14.3*** ***P < 0.0001 when compared withmonth 0. #P < 0.05 when compared with month 0.

The average of fasting glucose levels significantly decreased from thebeginning (98.2 mg/dL), to month 3 (94.1 mg/dL), to the end of the study(94.7 mg/dL). The decrease in plasma glucose levels were presented in 14subjects with impaired fasting glucose or diabetes (−16.9 mg/dL) and 134subjects with normal glucose levels (−3.1 mg/dL). These results indicatethat the multi-vitamin and mineral supplement may lower plasma glucoselevels.

Another objective of the study was to determine if the homocysteinelevels lowered after supplementation with the multi-vitamin and mineralsupplement of the present invention. As discussed above, homocysteine isnot inherently bad, but too much homocysteine may cause problems. Highlevels of homocysteine confers a risk of vascular disease, increases therisk of atherosclerosis, and may be associated with Alzheimer's disease.The following ranges provide the risk ranges for cardiovasculardiseases, as well as other homocysteine-related diseases:

5 micromoles per liter or less - very low risk 6-9 micromoles per literlow risk 10-12 micromoles per liter moderate risk 13-18 micromoles perliter high risk 19 micromoles per liter or higher very high risk

The preferable level of homocysteine is below 10 micromoles per liter.

It has been discovered that folic acid has the potential of dramaticallylowering homocysteine levels, particularly when combined with vitamin B6and B12. Another objective of the study was determine how well vitaminB6, B12, and folic acid were absorbed. The results of the effect of thesupplement on serum concentrations of vitamins and homocysteine areshown in Table 4 below.

TABLE 4 Effect of Supplement on The Serum Concentrations of Vitamins andHomocysteine Variable Month 0 Month 3 Month 6 Cysteine 271.7 ± 42.2278.1 ± 41.5 281.3 ± 42.5 (nmol/ml) Homocysteine  7.9 ± 2.4  6.7 ±1.7***  6.7 ± 1.9*** (nmol/ml) Pyridoxal-5-  75.2 ± 65.1 430.0 ±176.8*** 391.2 ± 170.3*** phosphate (pmol/ml) Folate (ng/ml)  9.3 ± 3.4 13.1 ± 3.8***  12.4 ± 4.0*** vitamin B 12 454.9 ± 138.2 729.3 ±234.0*** 800.3 ± 281.4*** (pg/ml) ***p < 0.0001 when compared with month0. **p < 0.0001 when compared with month 0.

As shown in Table 4, the levels of the vitamin B6, B12, and folic acidincreased significantly indicating that the vitamins were easily andreadily absorbed. As further shown in Table 3, the participants had anaverage of 7.9 nmol/ml of homocysteine at the first visit and an averageof 6.7 nmol/ml of homocysteine at the third visit. At the end of the sixmonth study, the participants had an average 12% reduction inhomocysteine levels. As is shown in Table 6 below, those participantswith a homocysteine level above 10 nmol/l at the first visit had a 31%reduction in homocysteine levels at the third visit. Therefore, themulti-vitamin and mineral supplement of the present invention may reducecardiovascular risk by decreasing homocysteine levels.

As discussed above, high levels of LDL cholesterol has been linked tothe development of atherosclerosis in the coronary arteries. Clogging ofthe arteries occurs after LDL cholesterol is oxidized within the bloodvessel walls after exposure to free radicals. The white blood cellsattempt to remove the damaged LDL cholesterol by engulfing them. Afteringesting the LDL cholesterol, the white blood cells cannot ridthemselves of the cholesterol and swell, beginning the process ofatherosclerosis. LDL cholesterol can fight the free radicals withantioxidants such as vitamin C and E, but before long the antioxidantsare depleted and the LDL is left defenseless. Another objective of thestudy was to determine if vitamin C, E, and beta-carotene in thesupplement reduced the oxidation of LDL cholesterol. The results of theeffects of the supplement on LDL oxidation kinetics are shown in Tables5 and 6 below.

TABLE 5 Effect of Supplement on LDL Oxidation Kinetics Variable Month 0Month 3 Month 6 LDL Oxidation 57.5 ± 13.9 63.5 ± 19.0*** 63.8 ± 16.3***Lag time (minutes) LDL Oxidation Rate  9.7 ± 3.0  7.1 ± 2.5***  6.0 ±2.0*** (umol/min/g protein) Lipid-Standard?  9.0 ± 0.3  1.3 ± 0.4*** 1.4 ± 0.4*** Vitamin C Lipid-Standard? 33.0 ± 11.3 55.0 ± 23.4*** 49.5± 18.0** Vitamin E Lipid-Standard?  0.2 ± 0.2  0.4 ± 0.3***  0.4 ±0.3*** Beta-Carotene ***p < 0.0001 when compared with month 0. **p <0.0001 when compared with month 0.

TABLE 6 Effect of Supplement on the Serum Concentrations of Homocysteineand LDL oxidation % change % change Subgroup Month 0 Month 3 (0-3 M)Month 6 (0-6 M) Homocysteine HCT ≦ 10 (nmol/ml) 128 7.2 ± 1.6 6.3 ± 1.3−10*** 6.4 ± 1.7  −8*** (nmol/ml) HCT > 10 (nmol/ml) 22 12.0 ± 2.2  8.8± 2.0 −27*** 8.1 ± 1.9 −31*** LDL Oxidation LDL ≦ 130 (mg/dl) 114 9.6 ±3.1 7.1 ± 2.7 −17*** 5.9 ± 1.9 −35*** Rate LDL > 130 (mg/dl) 28 10.2 ±2.3  7.0 ± 2.1 −22*** 6.8 ± 2.1 −24*** (umol/min/g) Oxidation Lag LDL ≦130 (mg/dl) 118 57.3 ± 14.2 63.2 ± 20.2  18*** 63.7 ± 17.2  23*** Time(minutes) LDL > 130 (mg/dl) 28 58.3 ± 12.5 64.9 ± 12.5  16*** 63.0 ±12.8  12*** ***p < 0.0001

Measurement of LDL oxidation include lag time and oxidation rate. Lagtime is a measurement (in minutes) of the susceptibility of LDLcholesterol to oxidize, thus, the longer the duration the better. Theparticipants had a significant increases in lag time from an average of57.5 minutes at the first visit to 63.8 minutes at the third visit. Theoxidation rate is the rate at which the LDL oxidizes and a slower rateis preferable. The participants had a significant decrease in oxidationrate from 9.7 umol/min/g protein at the first visit to 6.0 umol/min/gprotein at the third visit, a 32% reduction. It is also noted that theblood levels of vitamin C, E, and beta-carotene significantly increasedfrom the first visit to the third visit, thus indicating that theseantioxidants were well absorbed. Therefore, the multi-vitamin andmineral supplement of the present invention may reduce cardiovascularrisk by decreasing the susceptibility of LDL to oxidation.

While various embodiments of a multi-vitamin and mineral supplement havebeen disclosed, it should be understood that modifications andadaptations thereof will occur to one skilled in the art. Other featuresand aspects of this invention will be appreciated by those skilled inthe art upon reading and comprehending this disclosure. Such features,aspects, and expected variations and modifications of the reportedresults and examples are clearly within the scope of the invention wherethe invention is limited solely by the scope of the following claims.

Having thus defined the invention, it is claimed:
 1. A multi-vitamin andmineral supplement for administration to humans, the supplementcomprising: from about 5000 I.U to about 10,000 I.U. of vitamin A; fromabout 1000 mg to about 2000 mg of vitamin C; about 400 I.U. of vitaminD; from about 800 I.U. to about 1200 I.U. of vitamin E; about 25 mcg ofvitamin K; about 3 mg of vitamin B1; about 10 mg of vitamin B2; about 20mg of vitamin B3; about 25 mg of vitamin B6; about 800 mcg of folicacid; about 400 mcg of vitamin B12; about 300 mcg of biotin; about 10 mgof pantothenic acid; up to about 18 mg of iron dosed in the form of apharmaceutically acceptable iron compound; about 150 mcg of iodine dosedin the form of a pharmaceutically acceptable iodine compound; about 400mg of magnesium dosed in the form of a pharmaceutically acceptablemagnesium compound; about 15 mg of zinc dosed in the form of apharmaceutically acceptable zinc compound; from about 100 mcg to 200 mcgof selenium; about 2 mg of copper dosed in the form of apharmaceutically acceptable copper compound; about 100 mcg of chromiumdosed in the form of a pharmaceutically acceptable chromium compound;about 400 mg of potassium dosed in the form of a pharmaceuticallyacceptable potassium compound; about 500 mg of choline dosed in the formof a pharmaceutically acceptable choline compound; about 10 mg oflycopene; and about 50 mg co-enzyme Q-10 dosed in the form of apharmaceutically acceptable co-enzyme Q-10 compound.
 2. Themulti-vitamin and mineral supplement of claim 1 wherein the supplementis further comprised of 6000 mcg of lutein and zeaxanthine.
 3. Themulti-vitamin and mineral supplement of claim 1 wherein vitamin A is inthe form of natural mixed beta carotene and carotenoids.
 4. Themulti-vitamin and mineral supplement of claim 1 wherein themulti-vitamin and mineral supplement is comprised of about 5000 I.U. ofvitamin A.
 5. The multi-vitamin and mineral supplement of claim 1wherein the multi-vitamin and mineral supplement is comprised of about10,000 I.U. of vitamin A.
 6. The multi-vitamin and mineral supplement ofclaim 1 wherein the multi-vitamin and mineral supplement is comprised ofabout 1000 mg of vitamin C.
 7. The multi-vitamin and mineral supplementof claim 1 wherein the multi-vitamin and mineral supplement is comprisedof about 2000 mg of vitamin C.
 8. The multi-vitamin and mineralsupplement of claim 1 wherein vitamin E is in the form of d-alphatocopherol succinate.
 9. The multi-vitamin and mineral supplement ofclaim 1 wherein the multi-vitamin and mineral supplement is comprised ofabout 800 I.U of vitamin E.
 10. The multi-vitamin and mineral supplementof claim 1 wherein the multi-vitamin and mineral supplement is comprisedof about 1200 I.U. of vitamin E.
 11. The multi-vitamin and mineralsupplement of claim 1 wherein B3 is in the form of niacinamide.
 12. Themulti-vitamin and mineral supplement of claim 1 wherein vitamin B6 is inthe form of pyridoxine hydrochloride.
 13. The multi-vitamin and mineralsupplement of claim 1 wherein vitamin B12 is in the form ofcyanocobalamin.
 14. The multi-vitamin and mineral supplement of claim 1wherein the biotin is d-biotin.
 15. The multi-vitamin and mineralsupplement of claim 1 wherein the pantothenic acid is d-calciumpantothenate.
 16. The multi-vitamin and mineral supplement of claim 1wherein the pharmaceutically acceptable iron compound is selected fromthe group consisting of ferrous fumarate, ferrous sulfate, ironcarbonyl, ferrous gluconate, ferrous chloride, ferrous lactate, ferroustartrate, ferrous succinate, ferrous glutamate, ferrous citrate, ferrouspyrophosphate, ferrous cholinisocitrate, ferrous carbonate,iron-sugar-carboxylate complexes, and combinations thereof.
 17. Themulti-vitamin and mineral supplement of claim 16 wherein thepharmaceutically acceptable iron compound is iron carbonyl.
 18. Themulti-vitamin and mineral supplement of claim 1 wherein themulti-vitamin and mineral supplement is substantially free of iron. 19.The multi-vitamin and mineral supplement of claim 1 wherein themulti-vitamin and mineral supplement is comprised of about 18 mg of apharmaceutically acceptable iron compound.
 20. The multi-vitamin andmineral supplement of claim 1 wherein the pharmaceutically acceptableiodine compound is selected from the group consisting of potassiumiodide, sodium iodide, and combinations thereof.
 21. The multi-vitaminand mineral supplement of claim 20 wherein the pharmaceuticallyacceptable iodine compound is potassium iodide.
 22. The multi-vitaminand mineral supplement of claim 1 wherein the pharmaceuticallyacceptable magnesium compound is selected from the group consisting ofmagnesium stearate, magnesium carbonate, magnesium oxide, magnesiumhydroxide, magnesium sulfate, and combinations thereof.
 23. Themulti-vitamin and mineral supplement of claim 22 wherein thepharmaceutically acceptable magnesium compound is magnesium oxide. 24.The multi-vitamin and mineral supplement of claim 1 wherein thepharmaceutically acceptable zinc compound is selected from the groupconsisting of zinc sulfate, zinc chloride, zinc oxide, and combinationsthereof.
 25. The multi-vitamin and mineral supplement of claim 24wherein the pharmaceutically acceptable zinc compound is zinc oxide. 26.The multi-vitamin and mineral supplement of claim 1 wherein themulti-vitamin and mineral supplement is comprised of about 100 mcg ofselenium.
 27. The multi-vitamin and mineral supplement of claim 1wherein the multi-vitamin and mineral supplement is comprised of about200 mcg of selenium.
 28. The multi-vitamin and mineral supplement ofclaim 1 wherein the pharmaceutically acceptable copper compound isselected from the group consisting of cupric oxide, cupric sulfate,cupric gluconate, and combinations thereof.
 29. The multi-vitamin andmineral supplement of claim 28 wherein the pharmaceutically acceptablecopper compound is cupric gluconate.
 30. The multi-vitamin and mineralsupplement of claim 1 wherein the pharmaceutically acceptable chromiumcompound is selected from the group consisting of yeast-bound chromium,GTF chromium, niacin-bound chromium, and combinations thereof.
 31. Themulti-vitamin and mineral supplement of claim 30 wherein thepharmaceutically acceptable chromium compound is chromium amino acidchelate.
 32. The multi-vitamin and mineral supplement of claim 1 whereinthe pharmaceutically acceptable potassium compound is selected from thegroup consisting of potassium chloride, potassium glycerophosphate,potassium citrate, potassium gluconate, and potassium phosphate.
 33. Themulti-vitamin and mineral supplement of claim 32 wherein thepharmaceutically acceptable potassium compound is potassium phosphate.34. The multi-vitamin and mineral supplement of claim 1 wherein thecholine is choline bitartrate.
 35. The multi-vitamin and mineralsupplement of claim 1 wherein co-enzyme Q-10 is ubiquinone.
 36. Themulti-vitamin and mineral supplement of claim 1 wherein the supplementis further comprised of a pharmaceutically acceptable carrier material.37. The multi-vitamin and mineral supplement of claim 1 which isadministered orally once per day.
 38. The multi-vitamin and mineralsupplement of claim 1 wherein the total daily dosage is divided andadministered in portions during the day.
 39. The multi-vitamin andmineral supplement of claim 1 wherein the dosage form is enteric coatedand compressed into a tablet or filled into hard of soft gelatincapsules.
 40. A multi-vitamin and mineral supplement for administrationto men and post-menopausal women, the supplement comprising: about 5000I.U of vitamin A; about 1000 mg of vitamin C; about 400 I.U. of vitaminD; about 800 I.U. of vitamin E; about 25 mcg of vitamin K; about 3 mg ofvitamin B1; about 10 mg of vitamin B2; about 20 mg of vitamin B3; about25 mg of vitamin B6; about 800 mcg of folic acid; about 400 mcg ofvitamin B12; about 300 mcg of biotin; about 10 mg of pantothenic acid;about 150 mcg of iodine dosed in the form of a pharmaceuticallyacceptable iodine compound; about 400 mg of magnesium dosed in the formof a pharmaceutically acceptable magnesium compound; about 15 mg of zincdosed in the form of a pharmaceutically acceptable zinc compound; about100 mcg of selenium; about 2 mg of copper dosed in the form of apharmaceutically acceptable copper compound; about 100 mcg of chromiumdosed in the form of a pharmaceutically acceptable chromium compound;about 400 mg of potassium dosed in the form of a pharmaceuticallyacceptable potassium compound; about 500 mg of choline dosed in the formof a pharmaceutically acceptable choline compound; about 10 mg oflycopene; and about 50 mg co-enzyme Q-10 dosed in the form of apharmaceutically acceptable co-enzyme Q-10 compound.
 41. A multi-vitaminand mineral supplement for administration to pre-menopausal women, thesupplement comprising: about 5000 I.U of vitamin A; about 1000 mg ofvitamin C; about 400 I.U. of vitamin D; about 800 I.U. of vitamin E;about 25 mcg of vitamin K; about 3 mg of vitamin B1; about 10 mg ofvitamin B2; about 20 mg of vitamin B3; about 25 mg of vitamin B6; about800 mcg of folic acid; about 400 mcg of vitamin B12; about 300 mcg ofbiotin; about 10 mg of pantothenic acid; about 18 mg of iron dosed inthe form of a pharmaceutically acceptable iron compound; about 150 mcgof iodine dosed in the form of a pharmaceutically acceptable iodinecompound; about 400 mg of magnesium dosed in the form of apharmaceutically acceptable magnesium compound; about 15 mg of zincdosed in the form of a pharmaceutically acceptable zinc compound; about100 mcg of selenium; about 2 mg of copper dosed in the form of apharmaceutically acceptable copper compound; about 100 mcg of chromiumdosed in the form of a pharmaceutically acceptable chromium compound;about 400 mg of potassium dosed in the form of a pharmaceuticallyacceptable potassium compound; about 500 mg of choline dosed in the formof a pharmaceutically acceptable choline compound; about 10 mg oflycopene; and about 50 mg co-enzyme Q-10 dosed in the form of apharmaceutically acceptable co-enzyme Q-10 compound.
 42. A multi-vitaminand mineral supplement for administration to athletes, the supplementcomprising: about 10,000 I.U of vitamin A; about 2000 mg of vitamin C;about 400 I.U. of vitamin D; about 1200 I.U. of vitamin E; about 25 mcgof vitamin K; about 3 mg of vitamin B1; about 10 mg of vitamin B2; about20 mg of vitamin B3; about 25 mg of vitamin B6; about 800 mcg of folicacid; about 400 mcg of vitamin B12; about 300 mcg of biotin; about 10 mgof pantothenic acid; about 18 mg of iron dosed in the form of apharmaceutically acceptable iron compound; about 150 mcg of iodine dosedin the form of a pharmaceutically acceptable iodine compound; about 400mg of magnesium dosed in the form of a pharmaceutically acceptablemagnesium compound; about 15 mg of zinc dosed in the form of apharmaceutically acceptable zinc compound; about 200 mcg of selenium;about 2 mg of copper dosed in the form of a pharmaceutically acceptablecopper compound; about 100 mcg of chromium dosed in the form of apharmaceutically acceptable chromium compound; about 400 mg of potassiumdosed in the form of a pharmaceutically acceptable potassium compound;about 500 mg of choline dosed in the form of a pharmaceuticallyacceptable choline compound; about 10 mg of lycopene; and about 50 mgco-enzyme Q-10 dosed in the form of a pharmaceutically acceptableco-enzyme Q-10 compound.